Flo-Ela

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Fluid Optimisation in Emergency Laparotomy

Aim

The aim of this trial is to establish whether the use of minimally invasive cardiac output monitoring to guide administration of intra-venous fluid (goal-directed haemodynamic therapy, GDHT), for patients aged 50 and over undergoing emergency laparotomy will reduce mortality within 90 days of randomisation, when compared with usual care.

Background/method

In this study we aim to trial a treatment used to guide the dose and timing of fluid administered into the bloodstream to patients during and shortly after surgery. We will trial this treatment, called “goal-directed haemodynamic therapy” (GDHT), in patients undergoing emergency bowel surgery (laparotomy). Emergency laparotomy is a common, major emergency, surgical procedure, performed to treat life-threatening conditions caused by cancer, infections or previous surgery. Over 30,000 people in England & Wales undergo this surgery annually at a cost of over £650m. Outcomes from emergency bowel surgery are poor; 14% of patients aged over 50 die within a month of surgery, rising to 20% within three months. As this surgery is so common, treatments that reduce death rates even slightly could save hundreds of lives. Major surgery and critical illness (both features of emergency bowel surgery) reduce blood flow to vital organs. This can cause serious complications and death after surgery. Fluids are given into the bloodstream to improve blood flow. Giving the right amount of fluid at the right time has a major impact on outcomes after surgery, but is hard to gauge accurately. Clinicians normally use signs such as heart rate and blood pressure to guide them, but these can be unreliable. GDHT aims to address this. It lets clinicians determine the dose and timing of fluid to give patients, guided by a monitor measuring the blood flow pumped by the heart. GDHT may be beneficial in planned surgery, but has not been properly tested in the complex setting of emergency bowel surgery. We aim to determine whether GDHT given to patients aged 50+ during and for up to 6 hours after emergency laparotomy reduces the number of deaths within 90 days of surgery.

Chief/Principal investigator

Chief investigator

Chief investigator

Dr Mark Edwards

Principal investigator

Principal investigator

Dr Rajneesh Sachdeva
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